MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 HUBLESS SILICONE FLAT DRAIN; SILICONE DRAIN

Catalog Number 0070440

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the was a strand of hair in the packaging of the drain.

Event Description

It was reported that there was a strand of hair in the drain package.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.The device used for the treatment.The device would not meet the specifications, and was affected by the reported failure.Visual evaluation of the returned sample noted that one opened (in original packaging), unused silicone flat drain.It was noted that there was a long curly hair within the package on top of the tubing portion of the drain.Although the reported event was confirmed, the root cause could not be determined.A potential root cause of this failure could be due to a defective /contaminated components from the supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review was not performed due to the labelling could not prevent the reported failure.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: HUBLESS SILICONE FLAT DRAIN
• Type of Device: SILICONE DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10070858
• MDR Text Key: 191674864
• Report Number: 1018233-2020-03269
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741090769
• UDI-Public: (01)00801741090769
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070440
• Device Lot Number: NGDZ1061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1